Lifescan Pocket Scan Blood Glucose Monitor System User manual

Owner’s Booklet
COMPACT BLOOD GLUCOSE MONITORING SYSTEM
Printed in U.S.A.
Patent(s) Pending © 1999 LIFESCAN INC.
AW*05023101A*
Visit the LifeScan website at
http://www.lifescan.com
LifeScan, UK
A Division of Ortho-Clinical Diagnostics
Enterprise House
Station Road
Loudwater, High Wycombe
Buckinghamshire HP10 9UF
United Kingdom
Registered in England 2549777. Registered office: Mandeville House,
62 The Broadway, Amersham, Buckinghamshire, England HP7 OHJ
LifeScan Customer Care FreePhone
UK 0800 121200
Republic of Ireland 1800 535676
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The enclosed LifeScan Blood Glucose Meter, as an electromedical device, has
been thoroughly tested and found to comply with the essential requirements of
the Electro Magnetic Compatibility Directive (EMC, 89/336/EEC), 1998.
1998
LifeScan Regulatory Affairs Europe
Div. d’Ortho-Clinical Diagnostics
1, rue Camille Desmoulins
92130 Issy les Moulineaux, France
Blood Glucose Meter: - EMC Directive (89/336/EEC)
Blood sampler: - MDD Directive (93/42/EEC), Class I
Lancets: 0120 - MDD Directive (93/42/EEC), Class IIa
Produced by:
Gainor Medical
2205 Hwy 42 North
McDonough, GA 30253 USA
LifeScan Inc.
1000 Gibraltar Drive
Milpitas, CA 95035 USA
LifeScan Customer Care FreePhone
UK 0800 121200
Republic of Ireland 1800 535676
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Owner’s Booklet
COMPACT BLOOD GLUCOSE MONITORING SYSTEM
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Glucose Ranges for
People Without
Diabetes (mmol/L)
Your Target Ranges
(mmol/L)
Before
breakfast
Before lunch
or dinner
1 hour
after meals
2 hours
after meals
Between
2 and 4 AM
3.9-5.8
3.9-6.1
Less than 8.9
Less than 6.7
Greater than 3.9
Source: Krall, L.P., and Beaser, R.S.: Joslin Diabetes Manual.
Philadelphia: Lea and Febiger (1989), 138.
Times of Day
Important Phone Numbers: Meter Serial No.
_________________
LifeScan Customer Care FreePhone number:
UK: 0800 121200, Republic of Ireland: 1800 535676
_________________________ _______________________
Healthcare Professional Pharmacist
_________________________ _______________________
Diabetes Specialist Nurse Other
II
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III
Dear PocketScan™ System Owner:
You have chosen one of the best blood glucose monitoring systems
available today. Your PocketScan System will provide you with the
accurate and fast blood glucose test results you need for better man-
agement of your diabetes. You just need to follow a few simple steps.
This owner’s booklet contains everything you need to know about
using the PocketScan System. Read it carefully and thoroughly before
you begin testing.
Blood glucose monitoring plays an important role in controlling your
diabetes. A long-term study of diabetes showed that keeping blood
glucose levels close to normal can reduce the risk of complications
by up to 60%.* The results you get with the PocketScan System can
help you and your healthcare professional monitor and adjust your
treatment plan to gain better control of your diabetes.
A Warranty Registration Card is included with your PocketScan
System. Please complete it and post it to us.
* American Diabetes Association position statement on the Diabetes Control and
Complications Trial (1993).
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IV
The PocketScan™ System is intended for use outside the body
(in vitro diagnostic use). It should be used only for testing
glucose (sugar) and only with fresh capillary whole blood
samples. It should not be used for the diagnosis of diabetes or
for the testing of newborns.
CAUTION:
Before using any product to test your blood sugar (blood glu-
cose), read all instructions and practice the test. Do all quality
control checks as directed and consult with a diabetes healthcare
professional.
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Important Information
•Severe dehydration and excessive water loss may cause false
low results. If you believe you are suffering from severe dehy-
dration, consult a healthcare professional immediately.
•
Test results below 3.3 mmol/L (60 mg/dL) mean low blood glu-
cose (hypoglycemia). Test results greater than 13.3 mmol/L (240
mg/dL) mean high blood glucose (hyperglycemia). If you get
results below 3.3 mmol/L (60 mg/dL) or above 13.3 mmol/L (240
mg/dL), and do not have symptoms, first repeat the test. If you
have symptoms or continue to get results that fall below 3.3
mmol/L (60 mg/dL) or above 13.3 mmol/L (240 mg/dL), follow
the treatment advice of your healthcare professional.
•If you are experiencing symptoms that are not consistent with
your blood glucose test results AND you have followed all
instructions described in the PocketScan™ Owner’s Booklet,
call your healthcare professional.
•A red blood cell count (Haematocrit) that is very high (above
55%) or very low (below 30%) can cause false results.
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VI
TABLE OF CONTENTS
GETTING STARTED
The Complete PocketScan™ Blood
Glucose Monitoring System 1
PocketScan™ Blood Glucose Meter 2
PocketScan™ Test Strips 4
BEFORE TESTING
Checking the Display 6
Coding the Meter 6
Checking the System with
PocketScan™ Control Solution 9
TESTING YOUR BLOOD 15
Getting a Drop of Blood 16
Step-by-Step Test Procedure 18
Special Messages 20
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VII
USING THE METER MEMORY 21
COMPARING METER AND LABORATORY RESULTS 24
CARING FOR YOUR METER
Maintenance 26
Batteries 26
DISPLAY MESSAGES AND PROBLEM-SOLVING GUIDE 28
SPECIFICATIONS 37
CHANGING METER SETTINGS
Changing the Date 38
Changing the Time 40
Changing the Unit of Measurement 41
GUARANTEE 42
TEST SUMMARY 43
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VIII
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1
The Complete PocketScan™ Blood
Glucose Monitoring System
The PocketScan Blood Glucose Monitoring
System consists of three main products: the
PocketScan™ Blood Glucose Meter,
PocketScan™ Test Strips, and PocketScan™
Control Solution. These products have been
designed, tested, and proven to work togeth-
er as a system to produce accurate blood glu-
cose test results. Use only PocketScan Test
Strips and PocketScan Control Solution with
the PocketScan Blood Glucose Meter.
Your PocketScan™ System includes:
•PocketScan™ Meter
•PocketScan™ Test Strips
•PocketScan™ Control Solution
•Penlet II Automatic Blood Sampler
•Sterile Lancets
•Owner’s Booklet
•Sporty Carrying Case
•Quick Reference Guide
•Warranty Registration Card
•Record Book
•Two 1.5 V #357 silver oxide batteries
(pre-installed).
GETTING
STARTED
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2
PocketScan™Blood
Glucose Meter
DISPLAY
Your test results are displayed here. The
large, easy-to-read display is where you
read the symbols and simple messages
that guide you through the test.
M BUTTON
The M (Mode) button is used to set up
the meter, enter the memory mode, and
turn the meter on and off.
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3
TEST PORT
The test port is where you insert the
PocketScan™ Test Strip for testing. The
meter will turn on automatically when
you insert a test strip.
C BUTTON
The C (Change) button
is used to change the
date and time, code
number, and unit of
measurement, as well
as to indicate control
solution tests and to
review test results while
in the memory mode.
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4
PocketScan™Test Strips
The PocketScan™ Blood Glucose
Monitoring System measures the amount
of sugar (glucose) in whole blood. Blood
is applied to the target area of the
PocketScan Test Strip. The test strip auto-
matically draws the required quantity of
blood into the reaction cell in which the
reaction takes place.
The PocketScan Test Strip consists of the
following parts:
Target Area
This is where you apply a small drop of
blood. The required amount of blood is
then automatically drawn into the reaction
cell.
Contact Bars
This end of the test strip is inserted into
the meter.
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5
Important Test Strip Information
•Store the test strip package in a cool, dry place below 30°C (86°F).
Keep away from direct sunlight and heat. Do not refrigerate.
•Store your test strips in their original vial only; do not transfer
them to a new bottle or any other container.
•After removing a PocketScan™ Test Strip from the vial,
replace the vial cap and close it tightly.
•You may touch the test strip anywhere on its surface when
removing it from the vial or inserting it into the meter.
•Use each test strip immediately after removing it from the package.
•Write the discard date on the vial label when you open it.
Discard PocketScan Test Strips and the vial three months after
first opening.
•Apply only PocketScan™ Control Solution or a blood sample
to the target area. Applying other substances to the target area
will cause inaccurate results.
•Do not use test strips beyond the expiration date printed on the
package since they may cause inaccurate results.
•Do not bend, cut, or alter a PocketScan Test Strip in any way.
WARNING: Keep the test strip vial away from children; the cap is a choking haz-
ard. Also, the cap contains a pouch filled with drying agents that may be harmful
if inhaled or swallowed and may cause skin or eye irritation.
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6
Checking the Display
Each time you insert a test strip into the
PocketScan™ Meter or turn the meter on,
all segments of the display will appear
briefly. This tells you that the system is per-
forming several self-checks and allows you
to confirm that all display segments are
working properly.
Coding the Meter
Code numbers are used to calibrate the
PocketScan™ Test Strips with the
PocketScan Meter for accurate results.
You must code the meter before using it
for the first time and then every time you
change to another vial of PocketScan Test
Strips. Check that the code number on the
meter display matches the code number
on the test strip vial.
BEFORE
TESTING
CAUTION:
If the code numbers do not match, test results may be inaccurate.
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STEP 1
Enter the Code Mode.
Start with the meter turned off. Insert a
PocketScan™ Test Strip to turn on the
meter. All segments of the display will
appear followed by the date and time.
Next, the code number will appear on the
display for three seconds.
STEP 2
Match the Code Numbers.
Compare the code number on the meter
display with the code number on the test
strip vial. If the two code numbers match,
you may begin testing. If they do not
match, follow Step 3. When you first use
the meter, three dashes (---) will appear,
showing that there is no code stored in the
memory.
(Example)
(Example)
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STEP 3
Code the Meter.
Use the C button to select the correct code.
Each time you press and release the C but-
ton, the number will increase by one. To
move faster, simply press and hold the C
button. After you have selected the correct
code number, it will flash for three sec-
onds and then appear solid for three sec-
onds. Then the symbol will appear,
indicating that the PocketScan™ System is
ready for testing.
(Example)
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9
Checking the System with
PocketScan™ Control Solution
PocketScan Control Solution is used to
check that the meter and test strips are
working together as a system and that
you are performing the test correctly. It is
very important that you do this simple
check routinely to make sure you get
accurate results.
PocketScan Control Solution contains a
known amount of glucose that reacts with
PocketScan™ Test Strips. Compare your
control solution test results with the expect-
ed range printed on the test strip vial label.
Control solution should be used to:
•Practice the test procedure.
•Make sure your meter and test strips are
working together properly.
•Ensure you are performing the test cor-
rectly.
For in vitro diagno
Not intended for h
consumption.
Unop
Lot N
AW 050
Control Solution
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10
Before you use the PocketScan™ Meter to
test your blood for the first time, practice
the procedure using control solution.
When you can do three tests in a row that
are within the expected range, you are
ready to test your blood.
Do a control solution test:
•When you begin using a new vial of test
strips.
•At least once a week.
•Whenever you suspect that the meter or
test strips are not working properly.
•When your blood glucose test results
are not consistent with how you feel, or
when you think your results are not
accurate.
•If you drop the meter.
The control solution test is similar to a
blood test except that you use
PocketScan™ Control Solution instead of
a drop of blood.
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